Defective Drugs

Although we are fortunate to have access to numerous medications intended to keep us well, every drug comes with some risk. That fact is hard to remember when we watch heart-warming, pharmaceutical commercials or read glossy ads promising renewed health and eternal well-being. These ads for prescription medications seem to be working and drug manufacturers are reaping the rewards.
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In fact, by 2011, prescription drugs accounted for nearly 10% of national health-related spending in the United States.(1) A study published in the Journal of the American Medical Association found that by 2012, nearly three in every five American adults had taken a prescription drug sometime in the previous month.(2)

New drugs can bring new risks for people who take them. Adverse drug events (ADEs) can lead to serious medical complications or death.

Estimates of how many people experience adverse drug events vary widely. The U.S. Department of Health and Human Services (HHS) has estimated adverse drug events are responsible for approximately 280,000 hospital admissions annually in the U.S.(3) The Institute for Safe Medication Practices (ISMP) has estimated that adverse drug events may have been responsible for between two and four million “serious, disabling, or fatal” injuries — including 128,000 patient deaths — in 2011.(4)

New drugs must be approved by the U.S. Food & Drug Administration (FDA) before they are sold. However, problems may still occur any time — before, during, or after the approval process. In fact, in recent years, several drugs have been linked with serious medical complications.

kidney icon Proton Pump Inhibitors (Nexium, Prilosec)
antibiotics icon Fluoroquinolone Antibiotics (Cipro, Avelox)
male gender icon Testosterone Replacement Therapy drugs (AndroGel, Fortesta)

If you suffered severe complications or were hospitalized due to an adverse drug event, or if a relative died due to prescription drug-related complications, you may want to discuss your legal options with a knowledgeable attorney.

Weitz & Luxenberg may be able to help. We invite you to call us for a free consultation (855) 274-5624.

Consult your doctor before stopping any prescribed medication.

How Are Drugs Approved?

In 1938, Congress enacted the Food, Drug, and Cosmetic (FDC) Act. Since then, the drug approval process has continued to evolve.

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In 1962, a sleeping pill called thalidomide, not approved for use in the U.S. due to efforts taken by Dr. Frances Kelsey at the FDA, resulted in thousands of babies being born with birth defects in Western Europe after their mothers had taken the drug during pregnancy. In response, Congress approved legislation requiring drug manufacturers to demonstrate to the FDA that any new drug is safe and effective for its intended use before selling it in the U.S.(5)

To secure FDA approval, drug manufacturers must conduct limited laboratory, animal, and clinical tests to determine how new drugs work and whether they are safe for use in humans.

A team at the FDA’s Center for Drug Evaluation and Research (CDER) composed of doctors, chemists, and other scientists reviews the evidence from these limited tests. If this group of FDA employees determines results presented from this testing demonstrate a level of safety and a measurable health benefit, the FDA may approve the drug.(6)  In some cases, especially for particular classes of drugs, the FDA may approve a drug with the stipulation that additional postmarketing testing be conducted or that postmarketing safety monitoring of particular adverse events be performed by the manufacturer.(7) (8)

dividing tray with prescription drugs

Potential Risks from New Drugs

Sometimes the tests do not reveal all the potential risks of a new drug. In addition, in some cases, drug manufacturers fail to present all their evidence, submit erroneous or falsified information, fail to report adverse events or other study protocol violations, or fail to protect the safety of clinical trial patients.(9)

In addition, drug manufacturers may not communicate the risks of a drug to the public, even if the FDA discovers a problem at a clinical trial site during an inspection or after a medical journal publishes the results of a clinical trial. In fact, sometimes the problems can be substantial enough to cause or contribute to serious medical complications or even death.

Somewhere down the line, the FDA may require updated label instructions or warnings for complications, but, by then, the damage may have already been done. For some patients, the warning may come too late.

Adverse effects of medicines have spawned thousands of lawsuits in recent years.

nexium pills

PPIs (Proton Pump Inhibitors)

Proton pump inhibitors (PPIs) are some of the most popular heartburn medications on the market. Drugs in this class include:

  • Nexium (esomeprazole)
  • Prilosec (omeprazole)
  • Prevacid (lansoprazole)
  • Dexilant (dexlansoprazole)
  • Protonix (pantoprazole)

Over-the-counter versions of PPIs include Prilosec OTC, Nexium 24HR and Prevacid 24HR. Prevacid, Prilosec, Nexium, and Protonix are also approved for use in children of specific ages.(21)

Several studies have found increased risk or incidence of serious kidney conditions in patients who have been exposed to PPIs — kidney conditions that may require dialysis or result in death. These include:

  • Chronic kidney disease (CKD)(22) (23)
  • Acute kidney injury (AKI)(24) (25)
  • Acute interstitial nephritis (AIN)(26) (27)
  • End-stage renal disease (ESRD)(28)

If you were diagnosed with any of these kidney injuries, or a relative died because of any of these conditions after taking a PPI, you may be able to seek compensation for your injuries.

By May 2017, Weitz & Luxenberg Practice Group Co-Chair Paul Pennock estimated more than 5,000 potential lawsuits across the U.S. were being considered due to the adverse effects of PPIs on kidneys. Weitz & Luxenberg alone is investigating approximately 3,500 cases. The claims involve kidney damage that is alleged to have developed from PPIs.(29) (30)

Nationwide, Paul Pennock noted roughly “122 suits have been filed, against AstraZeneca and other PPI makers such as Takeda Pharmaceuticals, Pfizer, and Procter & Gamble, which produces over-the-counter Prilosec.”(31)

Fluoroquinolone Antibiotics

Millions of Americans have taken fluoroquinolone antibiotics for bacterial infections, but in 2016 the FDA warned doctors to avoid prescribing them for certain urinary tract and respiratory infections. The agency determined the risks of serious side effects “generally outweigh the benefits for [these] patients …”(32)

Drugs in this class include:

  • Avelox (moxifloxiacin)
  • Cipro (ciprofloxacin)
  • Cipro XR (ciprofloxacin)
  • Factive (gemifloxacin)
  • Floxin (ofloxacin)
  • Levaquin (levofloxacin)
  • Maxaquin (lomefloxacin)
  • Noroxin (norfloxacin)
  • Proquin XR (ciprofloxacin)
  • Zagam (sparfloxacin)

The FDA has warned of potentially permanent side effects linked with fluoroquinolone antibiotics. In addition, studies have found increased risk of aortic aneurysms or dissections in patients taking fluoroquinolone antibiotics(33) (34) — conditions that can be life-threatening.(35) (36)

prescription pills bottles

Testosterone Replacement Therapy (TRT) Drugs

Drugs prescribed for testosterone replacement therapy (TRT) have been heavily marketed to treat “low testosterone,” or “Low T.” Multiple studies and reports have linked the use of these prescription drugs with significant increases in the risk of potentially serious and life-threatening cardiovascular complications.(37) (38) (39)

Some common brands of TRT drugs include:

  • Androderm
  • AndroGel
  • Axiron
  • Fortesta
  • Striant
  • Testim

In March 2015, the FDA required TRT drug manufacturers to warn patients of a potential increased risk of heart attack and stroke with testosterone prescription drugs. Less than a year earlier, the FDA had already added a warning to testosterone product labeling regarding the risk of blood clots in veins (venous thromboembolism), including deep vein thrombosis (DVT) and pulmonary embolism (PE), with use of prescription testosterone drugs.(40) (41)

The agency also cautioned against using the drugs to treat declining testosterone levels related to aging, noting testosterone replacement therapy is only indicated for “men who have low testosterone levels due to disorders of the testicles, pituitary gland, or brain that cause a condition called hypogonadism.” The FDA noted in its safety announcement it had “become aware that testosterone is being used extensively in attempts to relieve symptoms in men who have low testosterone for no apparent reason other than aging.” (42)

The FDA has noted abuse of testosterone, “usually at doses higher than those typically prescribed,” which can result in:(43)

  • Heart attack or failure
  • Stroke
  • Liver toxicity
  • Male infertility
  • Hostility
  • Aggression
  • Depression

As of early 2017, there were more than 6,000 lawsuits against makers of TRT drugs combined into a multidistrict litigation (MDL).(44) Plaintiffs claim they suffered heart attacks, strokes, deep vein thromboses, or pulmonary emboli after using the drugs.(45)

How Weitz & Luxenberg Can Help

For more than 30 years, Weitz & Luxenberg has been at the forefront of complex product liability-related litigation. Our attorneys have secured more than $17 billion in awards and settlements for clients.

Although past results are no guarantee of future success, Weitz & Luxenberg possesses the experience and resources necessary to pursue justice for clients harmed by the negligence of large drug companies.

If you have been injured by a defective drug, we can help you understand your legal options, beginning with a free consultation. Call us at (855) 274-5624 or fill out the form on this page. One of our representatives will be in touch with you shortly.

  1. Centers for Disease Control and Prevention. (2014, May). Health, United States, 2013. With Special Feature on Prescription Drugs (p. 20). Retrieved from
  2. Kantor, E.D., et al. (2015, November 3). Trends in Prescription Drug Use Among Adults in the United States From 1999-2012. Retrieved from
  3. U.S. Department of Health and Human Services. (2014). National Action Plan for Adverse Drug Event Prevention. Foreword (p. iii). Retrieved from
  4. Institute for Safe Medication Practices. (2012, May 31). QuarterWatch: Monitoring FDA MedWatch Reports. Anticoagulants the Leading Reported Drug Risk in 2011. Retrieved from
  5. U.S. Food & Drug Administration. (2014, December 19). About FDA. Significant Dates in U.S. Food and Drug Law History. Retrieved from
  6. U.S. Food & Drug Administration. (2016, January 29). Development & Approval Process (Drugs). Retrieved from
  7. U.S. Food & Drug Administration. (n.d.). Approved Risk Evaluation and Mitigation Strategies (REMS). Retrieved from
  8. U.S. Food & Drug Administration. (2016, March 10). Accelerated Approval Program. Retrieved from
  9. Seife, C. (2015, April). Research Misconduct Identified by the US Food and Drug Administration. Out of Sight, Out of Mind, Out of the Peer-Reviewed Literature. Retrieved from
  10. U.S. Food & Drug Administration. (2015, December 4). FDA Drug Safety Communication: FDA revises labels of SGLT2 inhibitors for diabetes to include warnings about too much acid in the blood and serious urinary tract infections. Retrieved from
  11. U.S. Food & Drug Administration. (2015, September 10). Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density. Retrieved from
  12. U.S. Food & Drug Administration. (2015, December 4). SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections. Retrieved from
  13. European Medicines Agency. (2017, February 10). PRAC concludes that diabetes medicine canagliflozin may contribute to risk of toe amputation. Risk may also apply to other medicines in the same class. Retrieved from
  14. U.S. Food & Drug Administration. (2016, May 18). FDA Drug Safety Communication: Interim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate. Retrieved from
  15. U.S. Food & Drug Administration. (2017, May 16). FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) Retrieved from
  16. U.S. Food & Drug Administration. (2016, June 14). Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings. Retrieved from
  17. U.S. Judicial Panel on Multidistrict Litigation. (2016, December 7). In re: Invokana (Canagliflozin) Products Liability Litigation. Retrieved from
  18. U.S. District Court, S.D. New York. (2016, December 16). Collins v. Bristol-Myers Squibb Co., AstraZeneca LP, and AstraZeneca Pharmaceuticals LP. Retrieved from
  19. U.S. District Court, S.D. New York. (2016, December 20). Cormier v. Bristol-Myers Squibb Co., AstraZeneca LP, and AstraZeneca Pharmaceuticals LP. Retrieved from
  20. U.S. Judicial Panel on Multidistrict Litigation. (2017, April 6). In re: Farxiga (Dapagliflozin) Products Liability Litigation. MDL No. 2776. Retrieved from
  21. Center for Medicare & Medicaid Services. (2013, August). Proton Pump Inhibitors: Use In Pediatric Patients. Retrieved from
  22. Arora, P., et al. (2016, August 3). Proton pump inhibitors are associated with increased risk of development of chronic kidney disease. Retrieved from
  23. Lazarus, B. (2016, February). Proton Pump Inhibitor Use and the Risk of Chronic Kidney Disease. Retrieved from
  24. Klepser, D.G., et al. (2013, July 16). Proton pump inhibitors and acute kidney injury: a nested case-control study. Retrieved from
  25. Antoniou, T., et al. (2015, April 2). Proton pump inhibitors and the risk of acute kidney injury in older patients a population-based cohort study. Retrieved from
  26. Sampathkumar, K. (2013, July). Acute interstitial nephritis due to proton pump inhibitors. Retrieved from
  27. Geevasinga, N., et al. (2006, May 4). Proton pump inhibitors and acute interstitial nephritis. Retrieved from
  28. Peng, Y-C., et al. (2016, April 18). Association Between the Use of Proton Pump Inhibitors and the Risk of ESRD in Renal Diseases: A Population-Based, Case-Control Study. Retrieved from
  29. U.S. Judicial Panel on Multidistrict Litigation. (2016, October 17). In re: Proton-Pump Inhibitor Products Liability Litigation. Memorandum in Support of Plaintiffs’ Motion for Transfer. Retrieved from
  30. Lupkin, S., & Bartolone, P. (2017, May 17). Does This Popular Stomach Drug Damage Your Kidneys? Retrieved from
  31. Ibid.
  32. U.S. Food & Drug Administration. (2016, May 12). FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together. Retrieved from
  33. Lee, C.C., et al. (2015, November). Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone. Retrieved from
  34. Daneman, N. (2015). Fluoroquinolones and collagen associated severe adverse events: a longitudinal cohort study. Retrieved from
  35. American Heart Association. (n.d.). Types of Aneurysms. Retrieved from
  36. Mayo Clinic. (n.d.). Diseases and Conditions. Aortic dissection. Retrieved from
  37. Basaria, S., et al. (2010, July 8). Adverse Events Associated with Testosterone Administration. Retrieved from
  38. Vigen, R., et al. (2013, November 6). Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. Retrieved from
  39. Finkle, W.D., et al. (2014, January 29). Increased Risk of Non-Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. Retrieved from
  40. U.S. Food & Drug Administration. (2014, June 19). FDA adding general warning to testosterone products about potential for venous blood clots. Retrieved from
  41. U.S. Food & Drug Administration. (2015, March 3). FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use. Retrieved from
  42. Ibid.
  43. U.S. Food & Drug Administration. (2016, October 25). Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement – Risks Associated With Abuse and Dependence. Retrieved from
  44. U.S. District Court, Northern District of Illinois. (n.d.). MDL 2545; In re: Testosterone Replacement Therapy Products Liability Litigation. Member Cases. Retrieved from
  45. U.S. Judicial Panel on Multidistrict Litigation. (2014, June 6). In re: AndroGel Products Liability Litigation. MDL No. 2545. Transfer Order. Retrieved from

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